Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18518 |
| Brand Name: | Abbott Acetaminophen Reagent |
| Model: | List Number: 2K99-20 |
| Affected: | Lots: 4579UQ04, 46121UQ07, 46561UQ08, 46207UQ09, 46953UQ12 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics Division Ground Floor, Building D 4 Pacific Rise Mt Wellington AUCKLAND 1640 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Sekisui Diagnostics P.E.I. Inc |
| Issue: | The current Instructions for use reports the Interference from N-acetylcysteine (NAC) evaluated on a commercially available analyser. Using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/L N-acetylcysteine (NAC) in a 104 mcg/mL (688 umol/L) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of NAC to a serum pool. Based on testing performed by Sekisui Diagnostics on an ARCHITECT cSystems instrument, the concentration of NAC at which acceptable acetaminophen results are obtained is 200 mg/L NAC in values from a 109 mcg/mL acetaminophen sample, tested two hours after the addition of NAC to a serum pool. The package insert is being updated accordingly based on these results. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/5/2015 |
